BlueCross BlueShield of Tennessee Medical Policy Manual

Bulking Agents for the Treatment of Vesicoureteral Reflux (VUR) and Incontinence

DESCRIPTION

Bulking agents are injectable substances used to increase tissue bulk. A number of products have been developed, and key factors in determining the optimal product are biocompatibility, durability, and absence of migration. The first FDA-approved product was cross-linked collagen (e.g., Contigen®, Zyderm®, Zyplast®). Other bulking agents include dextranomer/hyaluronic acid copolymer (Deflux®), carbon-coated beads (e.g., Durasphere®), spherical particles of calcium hydroxylapatite (CaHA) in a gel carrier (Coaptite®), and polydimethylsiloxane (Macroplastique®).

Vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney, most commonly seen in children. About one third of children with urinary tract infections (UTIs) are found to have VUR. In addition, there appears to be a genetic predisposition to VUR; therefore, children with UTI and their siblings often undergo evaluation for VUR, which can be definitively diagnosed by voiding cystourography.

The severity of reflux is described by a grading system, most commonly that of the International Reflux Study Group, which grades reflux from I to V. VUR is known to spontaneously resolve, particularly in lower grades of reflux (i.e., grades I and II), the antibiotics are given continuously until resolution, while surgery is reserved as initial therapy for those with high-grade reflux (grades III and IV) or as salvage therapy for those who are either noncompliant with antibiotic therapy, have breakthrough UTIs while receiving prophylactic therapy, or those with low-grade reflux that does not spontaneously resolve.

When used to treat stress urinary incontinence (SUI) in individuals who have failed conservative therapies (e.g., exercise, medication) bulking agents are injected periurethrally to increase the tissue bulk and thereby increase resistance to the outflow of urine. Bulking agents may be injected over a course of several treatments until the desired effect is achieved.

Several bulking agents have been studied for the treatment of fecal incontinence. Overall, the evidence is not sufficient to conclude whether bulking agents are an effective treatment for fecal incontinence.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Dextranomer/hyaluronic acid copolymer (Deflux®), a sterile, biodegradable gel, is the only agent specifically approved by the U. S. Food and Drug Administration (FDA) for the treatment of children with VUR grades II-IV in the United States. There is insufficient published evidence on the efficacy of autologous cellular therapy, autologous fat, autologous ear chondrocytes, and other treatments to treat urinary incontinence.

SOURCES

American Urological Association. (2010; confirmed in 2017). Management and screening of primary vesicoureteral reflux in children. Retrieved October 24, 2017 from http://www.auanet.org/guidelines/vesicoureteral-reflux-(2010-reviewed-and-validity-confirmed-2017).

American Urological Association. (2017). Surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU Guideline. Retrieved October 24, 2017 from http://www.auanet.org/guidelines/stress-urinary-incontinence-(sui)-new-(aua/sufu-guideline-2017).

Bharucha, A., Rao, S., & Shin, A. (2017). Surgical interventions and the use of device-aided therapy for the treatment of fecal incontinence and defecatory disorders.  Clinical Gastroenterology & Hepatology, 2017 Aug 22, doi: 10.1016/j.cgh.2017.08.023. [Epub ahead of print]. Abstract retrieved October 24, 2017 from PubMed database.

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2017). Injectable bulking agents for the treatment of urinary and fecal incontinence (7.01.19). Retrieved October 24, 2017 from BlueWeb. (39 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2017). Periureteral bulking agents as a treatment of vesicoureteral reflux (7.01.102). Retrieved October 24, 2017 from BlueWeb. (26 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for incontinence control devices (230.10) Retrieved October 24, 2017 from https://www.cms.gov/medicare-coverage-database.

Chapple, C., Cruz, F., Deffieux, X., Milani, A., Arlandis, S., Artibani, W., et al. (2017). Consensus statement of the European Urology Association and the European Urogynaecological Association on the use of implanted materials for treating pelvic organ prolapse and stress urinary incontinence. European Urology, 72 (3), 424-431. Abstract retrieved October 24, 2017 from PubMed database.

Hong, K., Kim, J., Ji, W., & Um, J. (2017). Midterm outcomes of injectable bulking agents for fecal incontinence: a systematic review and meta-analysis. Techniques in Coloproctology, 21 (3), 203-210. Abstract retrieved October 24, 2017 from PubMed database.

Mellgren, A., Matzel, K., Pollack, J., Hull, T., Bernstein, M., and Graf, W. (2014). Long-term efficacy of NASHA Dx injection therapy for the treatment of fecal incontinence. Neurogastroenterology & Motility, 26, 1087-1094. (Level 2 evidence)

National Institute for Health and Clinical Excellence (NICE). (2007, February). Injectable bulking agents for faecal incontinence. Retrieved December 16, 2015 from http://www.nice.org.uk.

National Institute for Health and Clinical Excellence (NICE). (2013, September). Urinary incontinence in women: management. Retrieved December 16, 2015 from http://www.nice.org.uk.

Riemsma, R., Hagen, S., Kirschner-Hermanns, R., Norton, C., Wijk, H., Andersson, K., et al. (2017). Can incontinence be cured? A systematic review of cure rates. BMC Medicine, 15:63. (Level 1 evidence)

U. S. Food and Drug Administration. (1999, September). Center for Devices and Radiological Health. Premarket Approval. Durasphere™ injectable bulking agent - P980053. Retrieved August 18, 2009 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2001, September). Center for Devices and Radiological Health. Pre-market Approval (PMA). Deflux injectable gel - P000029. Retrieved September 27, 2011 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2005, November). Center for Devices and Radiological Health. Premarket Approval. Coaptite® - P040047. Retrieved May 17, 2013 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2006, October). Center for Devices and Radiological Health. Premarket Approval. Macroplastique® implants - P040050. Retrieved October 20, 2009 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2011, May). Center for Devices and Radiological Health. Premarket Approval. Solesta® - P100014. Retrieved May 17, 2013 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2011, May). Center for Devices and Radiological Health. Premarket Approval. Solesta® - P100014. Retrieved May 17, 2013 from http://www.accessdata.fda.gov. 

Winifred S. Hayes, Inc. Hayes Brief. (2014, October; last update search August 2016). Solesta (NASHA Dx; Q-Med AB) for treatment of fecal incontinence. Retrieved October 24, 2017 from www.Hayesinc.com/subscribers. (23 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  3/8/2007

MOST RECENT REVIEW DATE:  11/9/2017

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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